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EUDAMEDFDA UDIClass A (EU MDR)
Ref 297753Ref 221039Ref 231651Ref 240930Ref 299701Ref 295982Ref 240658Ref 261194Ref 221719Ref 261193Ref 221730Ref 261197Ref 261191Ref 261203Ref 261204Ref 261182Ref 297642Ref 240922Ref 261195Ref 221742Ref 261192Ref 261198Ref 261196Ref 221328
Identity
- Trade Name
- BBL EUDAMEDBD BBL™ Streptocard™ Acid Test Latex F FDA UDIBD BBL™ Nitrate A Reagent Droppers FDA UDIBD BBL™ Fluid Thioglycollate Medium, Enriched FDA UDIBD BBL™ Columbia CNA Agar with 5% SB and BD BBL MacConkey II Agar BD I Plate™ FDA UDIBD BBL™ Dermatophyte Test Medium, Modified with Chloramphenicol FDA UDIBD BBL™ Voges-Proskauer B Reagent Droppers FDA UDIBD BBL™ Calcofluor White Reagent Droppers FDA UDIBD BBL™ Cooked Meat Medium with Glucose, Hemin and Vitamin K1 FDA UDIBD BBL™ 10% Potassium Hydroxide Reagent Droppers FDA UDIBD BBL™ Streptocard™ Acid Test Latex B FDA UDIBD BBL™ India Ink Reagent Droppers FDA UDIBD BBL™ OF Medium with Dextrose FDA UDIBD BBL™ Nitrate B Reagent Droppers FDA UDIBD BBL™ Urease Test Broth FDA UDIBD BBL™ Enriched Thioglycollate Medium FDA UDIBD BBL™ Acridine Orange Reagent Droppers FDA UDIBD BBL™ GN Broth FDA UDIBD BBL™ TSI Agar Slants FDA UDIBD BBL™ PYR Reagent Droppers FDA UDIBD BBL™ Catalase Reagent Droppers FDA UDIBD BBL™ Coagulase Plasma, Rabbit FDA UDIBD BBL™ Methylene Blue Loeffler Stain Droppers FDA UDIBD BBL™ Taxo™ Anaerobe Differentiation Discs Set FDA UDIBD BBL™ Voges-Proskauer A Reagent Droppers FDA UDI
- Generic Name
- Beta-haemolytic Streptococcus serological grouping IVD, kit, agglutination FDA UDINitrate reduction microbial reagent IVD FDA UDIEnriched broth culture medium IVD FDA UDIMultiple formulation agar culture medium IVD FDA UDIDifferential/selective agar culture medium IVD FDA UDIVoges-Proskauer (VP) microbial reagent IVD FDA UDIBiological stain IVD FDA UDIMultiple dermatophyte species culture isolate identification IVD, kit FDA UDIDifferential/selective broth culture medium IVD FDA UDIPyrrolidonyl arylamidase (PYR) microbial reagent IVD FDA UDICatalase production microbial reagent IVD FDA UDICoagulase production microbial reagent IVD FDA UDIMultiple anaerobic bacteria species culture isolate differentiation disc IVD FDA UDI
- Device Name
- BD BBL™ Saline, Normal, 5 mL and BD BBL™ Saline, Normal, 10 mL EUDAMEDBD BBL™ Nitrate A Reagent Droppers EUDAMEDFDA UDIBD BBL™ Voges-Proskauer B Reagent Droppers EUDAMEDFDA UDIBD BBL™ 10% Potassium Hydroxide Reagent Droppers EUDAMEDFDA UDIBD BBL™ OF Medium with Dextrose EUDAMEDFDA UDIBD BBL™ Nitrate B Reagent Droppers EUDAMEDFDA UDIBD BBL™ PYR Reagent Droppers EUDAMEDFDA UDIBD BBL™ Catalase Reagent Droppers EUDAMEDFDA UDIBD BBL™ Taxo™ Anaerobe Differentiation Discs Set EUDAMEDFDA UDIBD BBL™ Voges-Proskauer A Reagent Droppers EUDAMEDFDA UDIBD BBL™ TSI Agar™ Slants (Triple Sugar Iron Agar), 100 size K tubes EUDAMEDBD BBL™ Streptocard™ Acid Test Latex F EUDAMEDBD BBL™ Dermatophyte TestMedium, Modified withChloramphenicol EUDAMEDBD BBL™ Cooked Meat Medium with Glucose, Hemin & Vitamin K1 EUDAMEDBD BBL™ Coagulase Plasma, Rabbit EUDAMEDBD BBL™ India Ink Reagent Droppers EUDAMEDBD BBL™ Urease Test Broth EUDAMEDBD BBL™ GN Broth, 10 pack 8 mL and 100 pack 8 mL EUDAMEDBD BBL™ Methylene Blue Loeffler Stain Droppers EUDAMEDBD BBL™ Acridine Orange Reagent Droppers EUDAMEDBD BBL™ Fluid Thioglycollate Medium, Enriched EUDAMEDBD BBL™ Streptocard™ Acid Test Latex B EUDAMEDBD BBL™ Calcofluor White Reagent Droppers EUDAMEDBD BBL™ Enriched Thioglycollate Medium, 5 mL, BD BBL™ Enriched Thioglycollate Medium, 10 pack 8 mL and BD BBL™ Enriched Thioglycollate Medium, 100 pack 8 mL EUDAMEDBD BBL™ Streptocard™ Acid Test Latex F, one 2.5 mL bottle FDA UDIBD BBL™ Fluid Thioglycollate Medium, Enriched, Carton of 100 size K tubes FDA UDIBD BBL™ Columbia CNA Agar with 5% Sheep Blood and BD BBL MacConkey II Agar BD I Plate™, Carton of 100 plates FDA UDIBD BBL™ Dermatophyte Test Medium, Modified with Chloramphenicol, Package of 10 Size A Tubes FDA UDIBD BBL™ Calcofluor White Reagent Droppers, 50 FDA UDIBD BBL™ Cooked Meat Medium with Glucose, Hemin and Vitamin K1, Package of 10 size K tubes, 9 mL FDA UDIBD BBL™ Streptocard™ Acid Test Latex B, one 2.5 mL bottle FDA UDIBD BBL™ India Ink Reagent Droppers, 50 FDA UDIBD BBL™ Urease Test Broth, 3 mL, Package of 10 size K tubes FDA UDIBD BBL™ Enriched Thioglycollate Medium, 5 mL, Package of 100 tubes FDA UDIBD BBL™ Acridine Orange Reagent Droppers, 50 FDA UDIBD BBL™ GN Broth, 8 mL FDA UDIBD BBL™ TSI Agar Slants, Carton of 100 size K tubes FDA UDIBD BBL™ Coagulase Plasmas FDA UDIBD BBL™ Methylene Blue Loeffler Stain Droppers, 50 FDA UDI
- Model / Reference
- 297753 EUDAMED240930 EUDAMEDFDA UDI261197 EUDAMEDFDA UDI297642 EUDAMEDFDA UDI299701 EUDAMEDFDA UDI261193 EUDAMEDFDA UDI261195 EUDAMEDFDA UDI295982 EUDAMEDFDA UDI261191 EUDAMEDFDA UDI240922 EUDAMEDFDA UDI261194 EUDAMEDFDA UDI221328 EUDAMEDFDA UDI261198 EUDAMEDFDA UDI221719 EUDAMEDFDA UDI221742 EUDAMEDFDA UDI261182 EUDAMEDFDA UDI221730 EUDAMEDFDA UDI221039 EUDAMEDFDA UDI261196 EUDAMEDFDA UDI261203 EUDAMEDFDA UDI240658 EUDAMEDFDA UDI261204 EUDAMEDFDA UDI231651 EUDAMEDFDA UDI261192 EUDAMEDFDA UDI221601 FDA UDI
- Description
- BD BBL™ Streptocard™ Acid Test Latex F, one 2.5 mL bottle FDA UDIBD BBL™ Nitrate A Reagent Droppers FDA UDIBD BBL™ Fluid Thioglycollate Medium, Enriched, Carton of 100 size K tubes FDA UDIBD BBL™ Columbia CNA Agar with 5% Sheep Blood and BD BBL MacConkey II Agar BD I Plate™, Carton of 100 plates FDA UDIBD BBL™ Dermatophyte Test Medium, Modified with Chloramphenicol, Package of 10 Size A Tubes FDA UDIBD BBL™ Voges-Proskauer B Reagent Droppers FDA UDIBD BBL™ Calcofluor White Reagent Droppers, 50 FDA UDIBD BBL™ Cooked Meat Medium with Glucose, Hemin and Vitamin K1, Package of 10 size K tubes, 9 mL FDA UDIBD BBL™ 10% Potassium Hydroxide Reagent Droppers FDA UDIBD BBL™ Streptocard™ Acid Test Latex B, one 2.5 mL bottle FDA UDIBD BBL™ India Ink Reagent Droppers, 50 FDA UDIBD BBL™ OF Medium with Dextrose FDA UDIBD BBL™ Nitrate B Reagent Droppers FDA UDIBD BBL™ Urease Test Broth, 3 mL, Package of 10 size K tubes FDA UDIBD BBL™ Enriched Thioglycollate Medium, 5 mL, Package of 100 tubes FDA UDIBD BBL™ Acridine Orange Reagent Droppers, 50 FDA UDIBD BBL™ GN Broth, 8 mL FDA UDIBD BBL™ TSI Agar Slants, Carton of 100 size K tubes FDA UDIBD BBL™ PYR Reagent Droppers FDA UDIBD BBL™ Catalase Reagent Droppers FDA UDIBD BBL™ Coagulase Plasmas FDA UDIBD BBL™ Methylene Blue Loeffler Stain Droppers, 50 FDA UDIBD BBL™ Taxo™ Anaerobe Differentiation Discs Set FDA UDIBD BBL™ Voges-Proskauer A Reagent Droppers FDA UDI
Identifiers
- Catalog Number
- 240930 FDA UDI261197 FDA UDI297642 FDA UDI221601 FDA UDI299701 FDA UDI261193 FDA UDI261195 FDA UDI295982 FDA UDI261191 FDA UDI240922 FDA UDI261194 FDA UDI221328 FDA UDI261198 FDA UDI221719 FDA UDI221742 FDA UDI261182 FDA UDI221730 FDA UDI221039 FDA UDI261196 FDA UDI261203 FDA UDI240658 FDA UDI261204 FDA UDI231651 FDA UDI261192 FDA UDI
- Primary DI / UDI-DI
- 30382902977538 EUDAMED00382902409304 EUDAMEDFDA UDI30382902611975 EUDAMEDFDA UDI30382902976425 EUDAMEDFDA UDI30382902997017 EUDAMEDFDA UDI30382902611937 EUDAMEDFDA UDI30382902611951 EUDAMEDFDA UDI30382902959824 EUDAMEDFDA UDI30382902611913 EUDAMEDFDA UDI00382902409229 EUDAMEDFDA UDI30382902611944 EUDAMEDFDA UDI30382902213285 EUDAMEDFDA UDI30382902611982 EUDAMEDFDA UDI30382902217191 EUDAMEDFDA UDI30382902217429 EUDAMEDFDA UDI30382902611821 EUDAMEDFDA UDI30382902217306 EUDAMEDFDA UDI30382902210390 EUDAMEDFDA UDI30382902611968 EUDAMEDFDA UDI30382902612033 EUDAMEDFDA UDI30382902406588 EUDAMEDFDA UDI30382902612040 EUDAMEDFDA UDI00382902316510 EUDAMEDFDA UDI30382902611920 EUDAMEDFDA UDI10382902216015 FDA UDI
- Basic UDI-DI
- 038290IIOXDPSHE6 EUDAMED038290MLJTXYHYLJ EUDAMED038290HJFHUWIX9T EUDAMED038290LHRHITCLBL EUDAMED038290IWATYBVBGU EUDAMED038290IKKSAOED9H EUDAMED038290HLPGSWHSDR EUDAMED038290EDZAIPWL7E EUDAMED038290MQKFONEFDM EUDAMED038290DTDYTLIDEL EUDAMED038290MDXGKYWCEP EUDAMED038290JPEKPQSXDQ EUDAMED038290QBSJSEMFCV EUDAMED038290PEXCVVFQGU EUDAMED038290JPHIZMVEEW EUDAMED038290LLTAZPUUHG EUDAMED038290KADATNHWZQ EUDAMED038290OGQXROZRMN EUDAMED038290UETUFQHPL8 EUDAMED038290JYYXMLXUVX EUDAMED038290COBHWPGT6S EUDAMED038290VOLNFBFGHD EUDAMED038290CRSWFBDEDB EUDAMED038290LIOCZBPJB7 EUDAMED
- Unit of Use DI
- 00382902977537 EUDAMED00382902210399 EUDAMED00382902997016 EUDAMED00382902959823 EUDAMED00382902406587 EUDAMED00382902611943 EUDAMED00382902217190 EUDAMED00382902611936 EUDAMED00382902217305 EUDAMED00382902611974 EUDAMED00382902611912 EUDAMED00382902612032 EUDAMED00382902612049 EUDAMED00382902611820 EUDAMED00382902976424 EUDAMED00382902611950 EUDAMED00382902217428 EUDAMED00382902611929 EUDAMED00382902611981 EUDAMED00382902611967 EUDAMED00382902213284 EUDAMED
- FDA Product Code
- GTZ FDA UDIJTO FDA UDIJSG FDA UDIJSJ FDA UDIJSI FDA UDIJTS FDA UDIKZI FDA UDIJSH FDA UDIIDC FDA UDIJTL FDA UDI
- EMDN Code
- W0104010206 MEDIA IN TUBES (SOLID & LIQUID) EUDAMEDW0104080208 SINGLE TESTS (DISCS, STRIPS, DROPPERS...) EUDAMEDW0105011199 STREPTOCOCCAL REAGENTS - OTHER EUDAMEDW0104080203 GRAM POSITIVE - MANUAL IDENTIFICATION EUDAMEDW0104010899 BUFFERS, STAINS - OTHER EUDAMED
- GMDN Term
- Beta-haemolytic Streptococcus serological grouping IVD, kit, agglutination FDA UDINitrate reduction microbial reagent IVD FDA UDIEnriched broth culture medium IVD FDA UDIMultiple formulation agar culture medium IVD FDA UDIDifferential/selective agar culture medium IVD FDA UDIVoges-Proskauer (VP) microbial reagent IVD FDA UDIBiological stain IVD FDA UDIMultiple dermatophyte species culture isolate identification IVD, kit FDA UDIDifferential/selective broth culture medium IVD FDA UDIPyrrolidonyl arylamidase (PYR) microbial reagent IVD FDA UDICatalase production microbial reagent IVD FDA UDICoagulase production microbial reagent IVD FDA UDIMultiple anaerobic bacteria species culture isolate differentiation disc IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass B EUDAMEDClass I FDA UDI
- Regulation Number
- 866.3740 FDA UDI866.2660 FDA UDI866.2300 FDA UDI866.2360 FDA UDI864.1850 FDA UDI866.2330 FDA UDI866.2320 FDA UDI866.2160 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDIFDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
Microbial Substances
Yes
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 2.5 Milliliter FDA UDITotal Volume — 0.5 Milliliter FDA UDIDepth — 15 Millimeter FDA UDIOuter Diameter — 100 Millimeter FDA UDITotal Volume — 9 Milliliter FDA UDITotal Volume — 5 Milliliter FDA UDITotal Volume — 3 Milliliter FDA UDITotal Volume — 8 Milliliter FDA UDITotal Volume — 6.8 Milliliter FDA UDI
Bbl by Becton, Dickinson and Company — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 038290IIOXDPSHE6 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
- EUDAMED SRN
- US-MF-000018910
- Authorised Representative
- Becton Dickinson Ireland Limited IE-AR-000007610
Sources (49)
- EUDAMED 5a4ff1d7-529c-4711-83bc-98667af8af3b 61 fields · synced Oct 7, 2026
- FDA UDI 692c123e-e207-401b-97df-0de761216341 37 fields · synced May 22, 2026
- FDA UDI f2aee3f9-f632-4ac5-b9e3-62eda4503931 37 fields · synced May 27, 2026
- FDA UDI f638be62-4e59-47da-a431-5687c572eed2 36 fields · synced May 27, 2026
- FDA UDI 9beacd75-0925-42f2-a99e-dedf90e20d75 37 fields · synced May 29, 2026
- FDA UDI 739e11d1-afca-4b5e-adec-cab179efc41a 37 fields · synced May 29, 2026
- FDA UDI 4bc19554-8153-4b64-bd5b-5b72cf9a3061 37 fields · synced May 29, 2026
- FDA UDI ea768840-2a1c-4cd6-ab39-0e57deea3151 37 fields · synced May 30, 2026
- FDA UDI f9b0f05a-4cee-45f5-84b0-5a9e6016cb4d 37 fields · synced May 30, 2026
- FDA UDI 4c9f6ee3-eba1-429c-b4bb-2f9b9478af64 37 fields · synced May 30, 2026
- FDA UDI eb9bd9c9-fef8-4939-a3bd-809a077f958d 37 fields · synced May 30, 2026
- FDA UDI f16025e8-7e12-4c31-b912-686e6de0c8db 37 fields · synced May 30, 2026
- FDA UDI d4e6b985-5741-4783-9475-1a2465bc068f 37 fields · synced May 30, 2026
- FDA UDI 5664d6da-ee72-41d0-abf0-f4a9c5016f9d 37 fields · synced May 30, 2026
- FDA UDI 1428fd05-9026-497d-ae9a-d5b5d0761f25 37 fields · synced May 30, 2026
- FDA UDI 44b41f13-c9ab-4e21-9343-65ea246cf2b1 37 fields · synced May 30, 2026
- FDA UDI f638a2ca-7353-4179-8184-7434fa91ef97 37 fields · synced May 30, 2026
- FDA UDI a0260d49-1b9b-4773-905d-3d2d1418dfdf 37 fields · synced May 30, 2026
- FDA UDI aa18c520-a345-4c55-9b73-3d11cb6d67b0 37 fields · synced May 30, 2026
- FDA UDI 4ca5cf73-fb96-4275-abaf-2753f261948e 37 fields · synced May 30, 2026
- FDA UDI a3f1f846-2a91-4c72-8e10-6df96164b5e6 37 fields · synced May 30, 2026
- FDA UDI 18fc1619-b3f7-4b86-b8de-9d62fe58f26b 37 fields · synced May 30, 2026
- FDA UDI 0c7f6467-1dd8-46e6-b3f0-3bc48df8f581 37 fields · synced May 30, 2026
- FDA UDI 3056f278-1f41-41ce-b86a-6933ebae4d56 36 fields · synced May 30, 2026
- FDA UDI 38d01455-e28d-409a-8c0e-35728a2bbac0 37 fields · synced May 30, 2026
- EUDAMED e68e4b80-8d09-4f15-a880-a5e8a057b74a 61 fields · synced Jul 8, 2026
- EUDAMED a7c2ff5c-df7d-4166-a35a-50cd2f436f21 61 fields · synced Jul 9, 2026
- EUDAMED e64ab1d3-13eb-4bcc-916a-4cc4d9e1de23 61 fields · synced Jul 9, 2026
- EUDAMED 9ba7bc89-878c-4265-8041-d725b7f8befd 61 fields · synced Jul 10, 2026
- EUDAMED 99e92044-86b7-4922-8b7c-94d40946ac31 61 fields · synced Jul 10, 2026
- EUDAMED 3bc84fb1-e5a4-4b4d-ba99-9353f43880c4 61 fields · synced Jul 12, 2026
- EUDAMED ba2224b6-05c1-446c-a2dd-f8616eaee630 61 fields · synced Jul 12, 2026
- EUDAMED ec6c3e26-631e-4778-a121-76a4f0ed7989 61 fields · synced Jul 13, 2026
- EUDAMED cfcd6a57-6f94-44cb-a0a3-3c431eb87ef8 61 fields · synced Jul 13, 2026
- EUDAMED 5e132c88-2e6e-40cb-a5aa-24f96a297bb7 61 fields · synced Jul 14, 2026
- EUDAMED 9f4220fe-92d0-45b7-8835-ff2aa4c2dc37 61 fields · synced Jul 14, 2026
- EUDAMED dbbbb46e-1cc0-4f46-aded-0d9c04da8ec6 61 fields · synced Jul 14, 2026
- EUDAMED 246439ea-0beb-4616-a94a-af6cd242e8d4 61 fields · synced Jul 14, 2026
- EUDAMED 5b98982e-da19-490e-8164-7cbef1667267 61 fields · synced Jul 17, 2026
- EUDAMED edec268b-5f04-4fe2-9c6c-8b8999ad7626 61 fields · synced Jul 18, 2026
- EUDAMED fa1ad0a8-52a6-4ca0-99a6-794b7d685aa7 61 fields · synced Jul 20, 2026
- EUDAMED 8efbca3f-9de2-48ec-93e1-1e9f3a6a13b0 61 fields · synced Jul 21, 2026
- EUDAMED e80f4315-ab5e-4ec4-bebb-fff3410d7216 61 fields · synced Jul 21, 2026
- EUDAMED 8e925566-41f6-42f5-b4ac-938918abe69d 61 fields · synced Jul 28, 2026
- EUDAMED 39eca5a8-e35a-4197-9aa0-d327103e65b4 61 fields · synced Jul 29, 2026
- EUDAMED 584b7225-9ede-4647-a039-3949a5ad3c35 61 fields · synced Jul 30, 2026
- EUDAMED 659b74ce-8130-4e60-8c1a-4207ed1e952f 61 fields · synced Jul 31, 2026
- EUDAMED 6bbcb164-b72f-4fe0-89f7-245950b80771 61 fields · synced Jul 31, 2026
- EUDAMED fb59241b-b6b2-4322-a5ad-4d2340d3f164 61 fields · synced Oct 7, 2026